Identification of Mechanism in the Erythroid Response in Patients With Myelodysplasia Undergoing Chelation Therapy

Completed

• Conditions: Aplastic Anemia; Myelofibrosis; Myelodysplasia

• Registration Number: NCT01956799
• Lead Sponsor: Fondazione Italiana Sindromi Mielodisplastiche-ETS

Brief Summary

The study aims to evaluate the molecular mechanism underlying the erythroid response observed in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with Deferasirox or Deferoxamina.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-08
• Primary Completion: 2018-07
• Study Completion: 2019-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patients aged 18 and older
2. Diagnosis of Myelodysplasia, myelofibrosis or aplastic anemia
3. transfusion-dependent anemia undergoing chelation therapy with deferasirox or deferoxamine

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the molecular mechanism underlying the erythroid response	12 months	The primary outcome is to evaluate the molecular mechanism underlying the erythroid response (hemogoblin increase and reduction or elimination of trasfusion dependence) observed in some patients with myelodysplasia, myelofibrosis and aplastic anemia treated with Deferasirox or Deferoxamina

Trial Locations

Locations (20)

Ematologia, AO SS. Antonio e Biagio; 🇮🇹 Alessandria, AL, Italy

Clinica di Ematologia, AOU Ospedale di Torrette; 🇮🇹 Ancona, AN, Italy

Ematologia con trapianto, AOU Policlinico di Bari; 🇮🇹 Bari, BA, Italy

Istituto di Ematologia e Oncologia Medica, Policlinico S.Orsola; 🇮🇹 Bologna, BO, Italy

Ematologia, Spedali Civili; 🇮🇹 Brescia, BS, Italy

Struttura complessa di Ematologia, ASO S.Croce e Carle; 🇮🇹 Cuneo, CN, Italy

Cattedra di Ematologia Policlino Careggi; 🇮🇹 Firenze, FI, Italy

Clinica Ematologica, Università di Genova; 🇮🇹 Genova, GE, Italy

Ematologia, AO S. Andrea; 🇮🇹 Roma, Italy

U.O. Clinica Medicina Interna, IRCCS San Martino IST; 🇮🇹 Genova, GE, Italy

UO Ematologia e CTMO, Ospedale Civile G. da Saliceto; 🇮🇹 Piacenza, PC, Italy

Struttura Cattedra di Ematologia e CTMO, AOU di Parma; 🇮🇹 Parma, PR, Italy

Ematologia, Università di Padova; 🇮🇹 Padova, PD, Italy

Ematologia e Centro Trapianti, Centro di Riferimento Oncologico della Basilicata; 🇮🇹 Rionero in Vulture, PZ, Italy

Ematologia 2, AOU Città della Salute e della Scienza; 🇮🇹 Torino, TO, Italy

S.C.D.U. Ematologia e Terapie cellulari, Ospedale Mauriziano; 🇮🇹 Torino, TO, Italy

Medicina Interna II Divisione di Ematologia, Ospedale S. Luigi Gonzaga; 🇮🇹 Orbassano, TO, Italy

UOC Ematologia, Ospedale S.Eugenio; 🇮🇹 Roma, Italy

Policlinico A.Gemelli; 🇮🇹 Roma, Italy

UOC Ematologia, AO S. Giovanni Addolorata; 🇮🇹 Roma, Italy